Delhi High Court Sets Aside Rejection of Sequenom’s Patent Application for Non-Invasive Prenatal Testing

In this case, the appellants had sought patent protection for a biotechnological invention relating to a non-invasive prenatal testing method that detects foetal chromosomal abnormalities through cell-free foetal DNA present in maternal plasma. The application was examined and eventually refused by the Patent Office on the ground that it constituted a mere diagnostic method falling within the prohibition of Section 3(i) of the Patents Act, 1960. The Controller also held that the claimed invention lacked inventive step and clarity in technical terms. Aggrieved by the rejection, the applicants approached the appellate forum contending that the Patent Office failed to appreciate the scientific distinction between a clinical diagnostic procedure and a laboratory-based screening method with technical innovation.

The appellants argued that the claimed method did not involve any in-vivo testing on human subjects but merely analysed genetic material isolated from plasma samples, and therefore did not fall within the bar under Section 3(i). They also submitted that the invention introduced a novel approach to detecting aneuploidies using quantitative DNA analysis, which was neither obvious nor anticipated in prior art. The Controller, however, had not engaged with the technical data or comparative expert reports furnished by the applicants.

Issue Raised: Whether the Patent Office was justified in rejecting the application as a non-patentable diagnostic method under Section 3(i) without a scientific evaluation of the claimed technical features.

High Court’s Decision: The High Court set aside the impugned order and directed the Patent Office to re-examine the application in light of its scientific components and claimed technical effects. The Court observed that a blanket categorisation of a biological screening process as a “diagnostic method” under Section 3(i) was erroneous if the invention involved novel technical steps and did not directly diagnose a disease in a human subject. The Controller was also directed to give a reasoned decision on inventive step and clarity after granting a hearing to the applicants and allowing filing of updated technical data.

Emphasising that patentability in the life sciences requires careful scientific scrutiny rather than a mechanical application of Section 3(i), the Court remitted the matter for fresh consideration within a specified period and directed the Patent Office to record findings on each ground independently. The appeals were thus allowed for statistical purposes and the matter remanded for re-evaluation.

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